Criteria for Review under Expedited Category 2 (45 CFR 46.110)

Research can be reviewed under expedited category 2 when collection of blood meets specific criteria. These details as well as risks of blood collection should be outlined in the protocol and consent for the IRB’s review and consideration. If these details are not included, your submission may be returned. If the below criteria are not met, convened board review is required to determine the risk of the study (minimal or greater than minimal).

• Procedure/Method

  Collection of blood via finger stick, heel stick, ear stick, or venipuncture. Note: arterial collection is not included.

• Volume in Targeted Populations

  • Healthy, non-pregnant adults who weigh at least 110 pounds: the amount drawn may not exceed 550 ml
  • Other (i.e., non-healthy) adults and children considering the age, weight, and health of the subjects: the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg

• Timing

  The amount may not exceed the volume limit above (see item 2) in an 8 week period

• Frequency

  Collection may not occur more frequently than 2 times per week

Methods for Minimizing Risk

1. Limiting Blood Draws in Severely Sick Patients

   Investigators (with input from overseeing physicians) should consider further limiting blood draws for research in subjects who may not be in good health (e.g. anemia, low cardiac output, pulmonary or hematopoietic problem). An overseeing physician has the authority to discontinue research blood draws. The investigator should consult with the overseeing physician about any health status changes.

2. Minimize Extra Sticks

   Extra sticks should be minimized whenever possible. Drawing extra blood during the time of standard blood draws (or when there is already an IV or lines in place that allow for small withdrawal amounts) is recommended.

3. Iron Supplementation and Hemoglobin Monitoring

   This may be required for children involved in studies that draw a large amount of blood.

4. No Direct Benefit

   For studies where there is no direct benefit and enrolling non-healthy participants, it is pertinent that the amount of blood collected does not exceed the limit so that it will not impact the subject’s clinical condition. Additionally, when the study involves children there must be rationale as to how the study is likely to yield generalizable knowledge which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition, and the risk must represent a minor increase over minimal risk.

5. Assess Maximum Allowable Blood Volume

   When including children or sick patients, consider the amount of blood being collected during clinical care as well as research. Utilize the chart below as a guide, along with blood volume calculators.

6.